PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: Did Astra-Zeneca illegally market Seroquel for off-label use?

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Did Astra-Zeneca illegally market Seroquel for off-label use?

The state of Pennsylvania thinks so. In February 2007, Pennsylvania filed a lawsuit against AstraZeneca, and other atypical makers, alleging the drug giant illegally marketed Seroquel off-label for unapproved uses.

Seroquel is only FDA approved to treat acute manic episodes associated with bipolar I disorder and schizophrenia, and yet it is one of the most widely prescribed drugs in the world.

And I'm not sure what's going on at AstraZeneca, but this company generates more whistleblowers than anyone else.

So someone thought a few documents might be interesting in light of the allegations above.

The documents below is what AstraZeneca is using to educate doctors about areas Seroquel is not approved for.

Click on them to read and view full size.

But there's more. Seroquel was approved for bipolar depression only very recently, in October 2006.

So what did AstraZeneca do? Well, they made sure doctors were well educated about this area six months before they got the indication. See the date on the business reply card below (click to enlarge).

Did any of this violate anything?

I guess the state of Pennsylvania may think so, but we'll see . . .

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Blogger CL Psych said...

This will be an interesting case. Clearly, AZ was pushing Seroquel for off-label uses, but they seemed to be doing so through the CME outfit, which appears to be a widely accepted practice.

It would be nice if such practices were to stop, as the current state of practice seems to state that direct off-label marketing is forbidden, but off-label marketing through a proxy is perfectly okay.


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